RESUMO
Background: Despite there being advanced treatment options, psoriasis remains an incurable and recurring disease. Noteworthy scholars of Unani (Greco-Arab) medicine have proposed many drugs and formulations for psoriasis but the scientific evidence on the same is scarce. Hence, trial formulations were selected for the study. Primary Study Objectives: This study was designed to evaluate the efficacy and safety of two herbal Unani formulations, MaÎjun Mundi and Qairuti Karnab, in the management of chronic plaque psoriasis (CPP). Methods/Design: This open-label, single-arm clinical trial was conducted on 33 participants, of whom 30 completed the 12-week treatment course. Setting: This study was conducted at the Central Research Institute of Unani Medicine (CRIUM), Hyderabad, Telangana, India, from 01 August 2018 to 25 May 2019. Participants: Participants of any gender aged 18 to 65 years with clinically diagnosed CPP and psoriasis area severity index (PASI) ≥ 10% were included in the trial. Interventions: The participants received 5 g of MaÎjun Mundi (a semisolid preparation) orally, twice daily with water, followed by the topical application of Qairuti Karnab (a homogenous paste) to cover the lesions over 12 weeks. Outcome Measures: The primary outcome measure was the change in PASI determined pre- and post-trial in terms of mean and percentage reduction. Secondary outcome measures were changes in patient global assessment (PGA) on a 100 mm visual analog scale, investigator global assessment (IGA) on a 6-point scale, and subjective parameters including erythema, induration, scaling, and itchiness. Results: The analysis revealed a significant reduction in the PASI score, with 12 subjects (40%) achieving PASI 75 and 3 subjects (10%) achieving PASI 90. Significant improvements were also observed in secondary outcome measures with no adverse events. Conclusion: The findings of the study indicate that the trial formulations exhibit a notable anti-psoriatic effect without any adverse effects. The formulations are worthy of further evaluation as an alternative treatment for CPP.
